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Inion CPS™ and Inion CPS™ Baby Bioabsorbable Fixation System

by Inion Oy 102 variants

Ref PLT-1027

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06438408000669 UDI-DI Date27 Aug 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDD EUDAMED NumberB-06438408000669 Basic UDI-DI 06438408000669UDI-DIDate17 Dec 2021RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0630-2011 FDA Unclassified (pre-2012) initiated 14 Apr 2010
    • Terminated Z-0631-2011 FDA Unclassified (pre-2012) initiated 14 Apr 2010

    Inadequate Instructions for Use. The stated strength retention is ambiguous and the maximum immersion time of the plates/meshed is not defined.

    • Terminated Z-1550-2010 FDA Unclassified (pre-2012) initiated 5 Mar 2010 on shared 510(k) K010352

    During a sampling inspection, 2 lots of screws did not meet shear and torsion testing specifications.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Inion CPS™ and Inion CPS™ Baby Bioabsorbable Fixation System EUDAMED
2.5 mm Inion CPS® GUDID
Generic Name
Orthopaedic fixation plate, bioabsorbable
Device Name
Inion CPS Plates
Model / Ref / Catalog
PLT-1027, 1
Primary DI / UDI-DI
06438408000669
Basic UDI-DI
B-06438408000669
510(k) Number
FDA Product Code
JEY
EMDN Code
P09120606 Osteosynthesis devices, biodegradable screws and bars
GMDN Term
Orthopaedic fixation plate, bioabsorbable
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
872.4760
EU market of registration
Finland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PLT-1027
GUDID
1
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000000646

Other devices from Inion, Ltd.

See all devices from Inion, Ltd. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No